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U.S. Department of Health and Human Services

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Percent of CDRH (ODE and OIR) 510(k) decisions meeting MDUFA goals during the month

Dictionary: The Medical Device User Fee Amendments (MDUFA II) require FDA to pursue a comprehensive set of device review performance goals, intended to significantly improve the timeliness and predictability of FDA’s review of new devices. MDUFA II performance goals are measured by receipt cohort. By using the decision cohort, this measure provides a different approach to monitoring MDUFA related 510(k) performance goals. The measure tracks the number of 510(k) decisions made during the month that were within 90 FDA days. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to a Premarket Approval (PMA).

Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency (SE) claims. A legally marketed device, as described in 21 CFR 807.92(a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate.

Information is current as of September 30, 2013

Fiscal Year - 2011

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TimeTargetPercent
Oct 20108592
Nov 20108593
Dec 20108587
Jan 20118591
Feb 20118588
Mar 20118588
Apr 20118592
May 20118593
Jun 20118595
Jul 20118594
Aug 20118593
Sep 20118595

FY 2011 Overall: 92%

Number of CDRH (ODE and OIR) 510(k) decisions made in 90 days or less during the month (meeting goal)

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A255
Nov 2010N/A208
Dec 2010N/A277
Jan 2011N/A250
Feb 2011N/A250
Mar 2011N/A243
Apr 2011N/A244
May 2011N/A248
Jun 2011N/A242
Jul 2011N/A222
Aug 2011N/A267
Sep 2011N/A275

FY 2011 Total: 2,981

Total number of CDRH (ODE and OIR) 510(k) decisions made during the month

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A278
Nov 2010N/A224
Dec 2010N/A320
Jan 2011N/A274
Feb 2011N/A283
Mar 2011N/A276
Apr 2011N/A265
May 2011N/A266
Jun 2011N/A256
Jul 2011N/A237
Aug 2011N/A287
Sep 2011N/A290

FY 2011 Total: 3,256

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.